Multi-lancet unit, method and lancet device using the multi-lancet unit, and method of assembling and/or making the multi-lancet unit

ABSTRACT

Multi-lancet unit for a lancet device. The unit includes a plurality of lancets arranged in a row. Each lancet has a front ends a needle which extends from the front end, and a rear end. The front end of at least one of the plurality lancets is removably connected to the rear end of another of the plurality of lancets. The lancet device utilizes the multi-lancet unit and includes a body and a holding member which supports the multi-lancet unit. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. applicationSer. No. 11/044,008 filed Jan. 28, 2005, the disclosure of which isexpressly incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a multi-unit lancet in which a plurality oflancets are arranged in series and/or one in front of the other. Thelancets are removably connected to each other and can be disconnectedfrom each other by twisting, pulling, bending, and/or any combination ofthese movements. The invention also relates to a method of assemblingand/or forming the multi-unit lancet assembly by individually formingeach lancet, arranging them in a row and connecting the lancets togetherin order to form a multi-lancet unit. The invention further relates to alancet device which uses the multi-lancet unit and to a method of usingthe lancet device to puncture a user's skin.

2. Discussion of Background Information

Lancet devices are commonly used to prick the skin of the user so thatone or more drops of blood may be extracted for testing. Some users,such as diabetics, for example, may have to test their blood sugarlevels several times a day. This may be accomplished by the user using asimple needle. However, this procedure is often problematic for the usersince the needle may be difficult to handle. Additionally, many userssimply cannot perform the procedure owing to either a fear of needles orbecause they lack a steady hand. As a result, lancet devices have beendeveloped which allow the user to more easily and reliably perform thisprocedure.

SUMMARY OF THE INVENTION

According to one illustrative aspect of the invention there is provideda multi-lancet unit for a lancet device, wherein the unit preferablycomprises a plurality of lancets arranged in a row. Each lancetpreferably comprises a front end, a needle which extends from the frontend, and a rear end. Preferably, the front end of at least one of theplurality lancets is removably connected to the rear end of another ofthe plurality of lancets.

The plurality of lancets may comprise at least two lancets. Theplurality of lancets may comprise at least three lancets. The pluralityof lancets may be between five lancets and twenty lancets. The pluralityof lancets may be between eight lancets and twelve lancets. Each of theplurality of lancets may comprise a generally cylindrical portion. Eachof the plurality of lancets may comprise a non-circular cross-sectionwhen viewed perpendicular to a center axis of the plurality of lancets.Each of the plurality of lancets may comprise a locking mechanism. Thelocking mechanisms may be generally equally spaced. Each of theplurality of lancets may comprise a locking recess.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body and aholding member which houses the multi-lancet unit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, atrigger, and a movable holding member which houses the multi-lancetunit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, atrigger, a movable holding member which houses the multi-lancet unit,and a mechanism for moving the holding member to a retracted trigger-setposition.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, aholding member which houses the multi-lancet unit, and a mechanism formoving the multi-lancet unit within the holding member.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, wherein the method comprisesplacing or arranging the lancet device adjacent against a user's skinand triggering the lancet device so that one of the plurality of lancetis caused to penetrate the user's skin.

The invention also provides a multi-lancet unit for a lancet device,wherein the unit comprises a plurality of lancets arranged in a row.Preferably, each lancet comprises a front end, a needle which extendsfrom the front end, a rear end, an opening extending into the rear end,and a locking mechanism. Preferably, the front end of at least one ofthe plurality lancets is removably connected to the rear end of anotherof the plurality of lancets.

The plurality of lancets may comprise at least two lancets. Theplurality of lancets may comprise at least three lancets. The pluralityof lancets may be between five lancets and twenty lancets. The pluralityof lancets may be between eight lancets and twelve lancets. Each of theplurality of lancets may comprise a generally cylindrical portion. Eachof the plurality of lancets may comprise a non-circular cross-sectionwhen viewed perpendicular to a center axis of the plurality of lancets.The locking mechanism may comprise a tapered recess. The lockingmechanisms may be generally equally spaced. The locking mechanism maycomprise a locking recess.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body and aholding member which houses the multi-lancet unit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, atrigger, and a movable holding member which houses the multi-lancetunit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, atrigger, a movable holding member which houses the multi-lancet unit;and a mechanism for moving the holding member to a retracted trigger-setposition.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, aholding member which houses the multi-lancet unit, and a mechanism formoving the multi-lancet unit within the holding member.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, wherein the method comprisesarranging the lancet device adjacent against a user's skin andtriggering the lancet device so that one of the plurality of lancet iscaused to penetrate the user's skin.

The invention also provides a method of making the multi-lancet unitdescribed above, wherein the method comprises forming each of theplurality of lancets and arranging the plurality of lancets in a row toform the multi-lancet unit.

The invention also provides a multi-lancet unit for a lancet device,wherein the unit comprises a plurality of lancets arranged in a row.Each lancet comprises a front end, a needle which extends from the frontend, a rear end, an opening extending into the rear end, and a lockingmechanism. A plurality of breakable and/or separable connections isutilized. Each breakable or separable connection is arranged to connectan adjacent pair of lancets.

The invention also provides a multi-lancet unit for a lancet device,wherein the unit comprises a plurality of lancets arranged one in frontof the other and each lancet comprising a front end, a needle whichextends from the front end, and a rear end. The front end of at leastone of the plurality lancets is removably connected to the rear end ofanother of the plurality of lancets.

The plurality of lancets may comprise two lancets. The plurality oflancets may comprise at least three lancets. The plurality of lancetsmay be between five lancets and twenty lancets. The plurality of lancetsmay be between eight lancets and twelve lancets. Each of the pluralityof lancets may comprise a generally cylindrical portion. Each of theplurality of lancets may comprise a non-circular cross-section whenviewed perpendicular to a center axis of the plurality of lancets. Atleast one of the plurality of lancets may comprise a locking mechanism.The locking mechanism may be one of a locking recess and a lockingprojection. At least one of the plurality of lancets may comprise atleast one of a locking recess and a locking member. The needle of atleast one of the plurality of lancets may be retractable.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body and aholding member which houses the multi-lancet unit. The lancet device mayalso comprise a body, a trigger, a movable holding member which isconfigured to receive the multi-lancet unit, and a mechanism for movingthe holding member to a retracted trigger-set position. The lancetdevice may comprise a body, a holding member which receives themulti-lancet unit, and a mechanism for moving the multi-lancet unitwithin the holding member.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, wherein the method comprisesarranging the lancet device adjacent against a user's skin andtriggering the lancet device so that one of the plurality of lancet iscaused to penetrate the user's skin. The invention also provides amethod of puncturing a surface of skin using the lancet device describedabove, wherein the method comprises arranging the lancet device adjacentagainst a user's skin and triggering the lancet device so that one ofthe plurality of lancet is caused to penetrate the user's skin. Theinvention also provides a method of puncturing a surface of skin usingthe lancet device described above, wherein the method comprisesarranging the lancet device adjacent against a user's skin andtriggering the lancet device so that one of the plurality of lancet iscaused to penetrate the user's skin.

The invention also provides a multi-lancet unit for a lancet device,wherein the unit comprises a plurality of lancets arranged in a row andeach lancet comprising a front end, a needle which extends from thefront end, a rear end, an opening extending into the rear end. The frontend of at least one of the plurality lancets is removably connected tothe rear end of another of the plurality of lancets.

The plurality of lancets may comprise two lancets. Each of the pluralityof lancets comprises a generally cylindrical portion. Each of theplurality of lancets may comprise a non-circular cross-section whenviewed perpendicular to a center axis of the plurality of lancets. Oneof the plurality of lancets may be configured to be non-removablyconnected to another of the plurality of lancets. One of the pluralityof lancets may be configured to be non-removably connected to another ofthe plurality of lancets after said lancets are separated from eachother and connected to each other in a different configuration. The unitmay further comprise a cap which is configured to be removably connectedto one of the plurality of lancets and configured to be non-removablyconnected to another of the plurality of lancets.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body and aholding member which houses the multi-lancet unit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, atrigger, and a movable holding member which receives or supports themulti-lancet unit.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, amovable holding member which receives or supports the multi-lancet unit,a mechanism for moving the holding member to a retracted trigger-setposition, and at least one of: a front cap arrangement connected to thebody; a front tip assembly coupled to a front end of the body; a frontassembly removably coupled to a front end of the body; and a tipassembly adjusting a penetration depth of a lancet needle being coupledto a front end of the body.

The invention also provides a lancet device utilizing the multi-lancetunit described above, wherein the lancet device comprises a body, aholding member which houses the multi-lancet unit, and a mechanism formoving the multi-lancet unit within the holding member.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, the method comprises arrangingthe lancet device adjacent against a user's skin and triggering thelancet device so that one of the plurality of lancet is caused topenetrate the user's skin.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, wherein the method comprisesarranging the lancet device adjacent against a user's skin andtriggering the lancet device so that one of the plurality of lancet iscaused to penetrate the user's skin.

The invention also provides a method of puncturing a surface of skinusing the lancet device described above, wherein the method comprisesarranging the lancet device adjacent against a user's skin andtriggering the lancet device so that one of the plurality of lancet iscaused to penetrate the user's skin.

The invention also provides a method of making the multi-lancet unitdescribed above, wherein the method comprises forming each of theplurality of lancets and arranging the plurality of lancets in a row toform the multi-lancet unit.

The invention also provides a method of making the multi-lancet unitdescribed above, wherein the method comprises forming each of theplurality of lancets and arranging the plurality of lancets in a row toform the multi-lancet unit.

The invention also provides a multi-lancet unit for a lancet device,wherein the unit comprises a plurality of lancets arranged in a row,each lancet comprising a front end, a needle which extends from thefront end, a rear end, an opening extending axially into the rear end,and a cap removably connected to a front one of the plurality oflancets.

Other exemplary embodiments and advantages of the present invention maybe ascertained by reviewing the present disclosure and the accompanyingdrawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention,in which like reference numerals represent similar parts throughout theseveral views of the drawings, and wherein:

FIG. 1 shows a side view of one embodiment of a multi-lancet unit. Theunit includes four removably connected lancets arranged one in front ofthe other. Each lancet includes a lancet needle;

FIG. 2 shows an enlarged view of the second lancet shown in the unit ofFIG. 1;

FIG. 3 shows a top view of the lancet shown in FIG. 2;

FIG. 4 shows a cross-section view of an end portion one embodiment of alancet holding member;

FIG. 5 shows a side view of FIG. 4;

FIG. 6 shows a top view of the retaining member used on the embodimentshown in FIGS. 4 and 5;

FIG. 7 shows a side view of the retaining member shown in FIG. 6;

FIG. 8 shows a side view of the lancet holding member shown in FIG. 5with the retaining member removed;

FIG. 9 shows another side view of the lancet holding member shown inFIG. 5. The view is rotated 90 degrees from that shown in FIG. 8;

FIG. 10 shows a cross-section view of the lancet holding member shown inFIGS. 4, 5, 8 and 9 with the multi-lancet unit installed therein. Thelancets are not shown in cross-section;

FIG. 11 shows a view similar to that of FIG. 10 with the multi-lancetunit being moved and/or advanced partially forward and out of the lancetholding member;

FIG. 12 shows a view similar to that of FIG. 11 with the multi-lancetunit being moved and/or advanced forward and out of the lancet holdingmember until the retaining member engages the next lancet therebytemporarily locking the multi-lancet unit in the next position;

FIG. 13 shows a view similar to that of FIG. 12 with the front mostlancet being removed from the multi-lancet unit;

FIG. 14 shows a cross-section of an end portion of another embodiment ofa lancet holding member which can be used with the multi-lancet unit;

FIG. 15 shows a side view of FIG. 14 rotated 90 degrees;

FIG. 16 shows a side view of FIG. 14 and illustrates deflection of theretaining members while the multi-lancet unit advances forward and outof the lancet holding member;

FIG. 17 shows a side view of one embodiment of a lancet device which caninclude the multi-lancet unit and the lancet holding member shown above;

FIG. 18 shows a cross-section view of the lancet device shown in FIG.17;

FIG. 19 shows a side view of another embodiment of a multi-lancet unitwhich can be used on the lancet device shown in FIGS. 17 and 18;

FIG. 20 shows the multi-lancet unit of FIG. 19 installed within thelancet device shown in FIGS. 17 and 18. The lancet device is shown inthe armed/trigger set position;

FIG. 21 shows the multi-lancet unit of FIG. 19 installed within thelancet device shown in FIGS. 17 and 18. The lancet device is shown inthe extended/triggered position;

FIG. 22 shows a partial end view of another embodiment of the lancetdevice, lancet holding member, and multi-lancet unit. This embodiment issimilar to that of FIGS. 20 and 21 except that the lancets, the lancetholding member and guide flanges of the lancet device includearrangements for linearly and non-rotatably guiding movement of theholding member within the lancet device and for linearly andnon-rotatably guiding movement of the multi-lancet unit within thelancet holding member;

FIG. 23 shows a partial end view of another embodiment of the lancetdevice, lancet holding member, and multi-lancet unit. This embodiment issimilar to that of FIGS. 20 and 21 except that the lancets, the lancetholding member and guide flanges of the lancet device includearrangements and/or an external shape for linearly and non-rotatablyguiding movement of the holding member within the lancet device and forlinearly and non-rotatably guiding movement of the multi-lancet unitwithin the lancet holding member;

FIG. 24 shows a side view of one embodiment of the multi-lancet unitwhich can be used in the lancet devices shown in FIGS. 22 and 23;

FIG. 25 shows a side view similar to that of FIG. 24 rotated 90 degrees;

FIG. 26 shows another embodiment of a lancet device which can utilizethe multi-lancet unit described above. This device is similar to thatshown in FIGS. 20 and 21 except that it additionally includes amechanism for re-setting and/or moving the lancet holding member backinto the trigger set/armed position;

FIG. 27 shows another non-limiting way in which the lancets can beremovably connected to each other. In this Figure, a single wrap ofconnecting tape is used to connect two adjacent lancets;

FIG. 28 shows a partial end view of another embodiment of the lancetdevice, lancet holding member, and multi-lancet unit. This embodiment issimilar to that of FIGS. 20 and 21 except that the lancets, the lancetholding member and guide flanges of the lancet device includearrangements and/or an external shape for linearly and non-rotatablyguiding movement of the holding member within the lancet device and forlinearly and non-rotatably guiding movement of the multi-lancet unitwithin the lancet holding member;

FIG. 29 shows five views of another embodiment of the lancet devicewherein the lancet devices uses a system for advancing the multi-lancetunit. The mechanism has the form of a slide button. This multi-lancetunit advancing system can be used on any of the lancet devices disclosedherein;

FIG. 30 shows an enlarged view of the multi-lancet unit advancing systemshown in FIG. 29;

FIG. 31 schematically shows a lancet device with a front cap;

FIG. 32 shows a cross-section view of another embodiment of themulti-lancet unit. This embodiment utilizes two or more lancets whicheach have a front projecting portion and a rear recess portion. A cap isremovably connected to the front projecting portion of the first lancet;

FIG. 33 shows a cross-section view of the cap which can be used on themulti-lancet unit of FIG. 32. The cap has the form of a generallycylindrical sleeve with an closed front end and an open rear end;

FIG. 34 shows a cross-section view of the multi-lancet unit shown inFIG. 32 with the cap removed;

FIG. 35 shows a cross-section view of the multi-lancet unit shown inFIG. 32 with the cap removed and after the multi-lancet unit is used topuncture the skin of a user. The needle which has been used is shown tohave contaminates, e.g., blood;

FIG. 36 shows a cross-section view of the front lancet of themulti-lancet unit shown in FIG. 32 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet;

FIG. 37 shows a cross-section view of the rear lancet of themulti-lancet unit shown in FIG. 32 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet;

FIG. 38 shows a cross-section view of the rear lancet of themulti-lancet unit shown in FIG. 32 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet and placed in a position behind the rearlancet;

FIG. 39 shows a cross-section view of the front lancet of themulti-lancet unit shown in FIG. 32 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet and placed in a position behind the rearlancet;

FIG. 40 shows a cross-section view of the multi-lancet unit shown inFIG. 32 and after the multi-lancet unit is used to puncture the skin ofa user and after the front lancet has been separated from the rearlancet and inserted into the rear lancet. At this point, themulti-lancet unit is ready to again puncture the skin of a user with afresh needle, i.e., the needle of the rear lancet which has assumed theposition of the front lancet. When the front lancet was positioned inthe rear end of the rear lancet, the needle was forced to retract intothe lancet;

FIG. 41 shows a cross-section view of the multi-lancet unit after it hasbeen used a second time to puncture the skin of a user. The cap is nowremovably connected the rear lancet which has become the front lancet;

FIG. 42 shows a cross-section view of another embodiment of themulti-lancet unit. This embodiment utilizes two or more lancets whicheach have a front projecting portion and a rear recess portion. A cap isremovably connected the from front projecting portion of the firstlancet;

FIG. 43 shows a cross-section view of the cap which can be used on themulti-lancet unit of FIG. 42. The cap has the form of a generallycylindrical sleeve with an closed front end and an open rear end;

FIG. 44 shows a cross-section view of the multi-lancet unit shown inFIG. 42 with the cap removed;

FIG. 45 shows a cross-section view of the front lancet of themulti-lancet unit shown in FIG. 42 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet;

FIG. 46 shows a cross-section view of the rear lancet of themulti-lancet unit shown in FIG. 42 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet;

FIG. 47 shows a cross-section view of the rear lancet of themulti-lancet unit shown in FIG. 42 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet and placed in a position behind the rearlancet;

FIG. 48 shows a cross-section view of the front lancet of themulti-lancet unit shown in FIG. 42 and after the multi-lancet unit isused to puncture the skin of a user and after the front lancet has beenseparated from the rear lancet and placed in a position behind the rearlancet;

FIG. 49 shows a cross-section view of the multi-lancet unit after it hasbeen used a second time to puncture the skin of a user. The cap is nowremovably connected the rear lancet which has become the front lancet;

FIG. 50 shows a partial cross-section view of one non-limiting way inwhich the cap of the above-noted embodiments can be connected to thefront projecting portion of the front lancet or rear lancet. The cap isshown threadably connected to the front projecting portion of the frontlancet;

FIG. 51 shows a partial cross-section view of one non-limiting way inwhich the front and rear lancets can be connected to each other. Thefront projecting portion of the rear lancet is shown threadablyconnected to the rear recess portion of the front lancet;

FIG. 52 shows a partial cross-section view of one non-limiting way inwhich the multi-lancet unit can be positioned within a front receivingportion of a conventional lancet holding member of a lancet device;

FIG. 53 shows a cross-section view of still another embodiment of themulti-lancet unit. This embodiment utilizes two or more lancets whicheach have a front projecting portion and a rear recess portion. A cap isremovably connected the from front projecting portion of the firstlancet;

FIG. 54 shows a cross-section view of the multi-lancet unit of FIG. 53after it has been used a second time to puncture the skin of a user. Thecap is now non-removably connected to the rear lancet which has becomethe front lancet;

FIG. 55 shows a cross-section view of still another embodiment of themulti-lancet unit. This embodiment utilizes two or more lancets whicheach have a front projecting portion and a rear recess portion. A cap isremovably connected the from front projecting portion of the firstlancet; and

FIG. 56 shows a cross-section view of the multi-lancet unit of FIG. 55after it has been used a second time to puncture the skin of a user. Thecap is now non-removably connected to the rear lancet which has becomethe front lancet. The front lancet has also become non-removablyconnected to the rear end of the rear lancet, which is now the frontlancet.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the embodiments of the present invention onlyand are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the present invention. In this regard, no attemptis made to show structural details of the present invention in moredetail than is necessary for the fundamental understanding of thepresent invention, the description taken with the drawings makingapparent to those skilled in the art how the several forms of thepresent invention may be embodied in practice.

FIGS. 1-3 show a first non-limiting embodiment of a lancet assembly ormulti-lancet unit LA. The unit LA includes a plurality of lancets L1,L2, L3 and a terminating or rear end lancet which is made up of a lastlancet LL and a dummy lancet DL. These rear lancet members LL and DL arepreferably non-removably connected to each other. The last lancet LL andthe lancets L1-L3 (or L1-LN depending on the desired number N of lancetsin a unit LA) are generally identical in size, shape and configurationwith the exception that the last lancet LL need not be provided with theconnecting members CM. Instead, the last lancet LL and the dummy lancetDL can be formed as a one-piece member. As can be seen in FIG. 2, eachlancet, e.g., lancet L1, has body portion CBP which can be generallycylindrical. As can be seen in FIG. 3, a rear end of each lancet, e.g.,lancet L1, includes a plurality of connecting projections or members CMand a generally centrally arranged lancet needle opening LNO which issized to receive therein a lancet needle LN of an adjacent rear lancet,e.g., lancet L2. The particular number, size, shape and arrangement ofthe connecting members CM is not of particular importance provided thata stable yet breakable connection is ensured between the adjacentlancets. In this regard, the connection should be strong enough to allowa user pull the unit LA out of the lancet holding member LHM (see FIGS.11 and 12) until the unit LA reaches the next locking or retainingposition to allow for the use of a new lancet, e.g., the next adjacentlancet L2. The connection should also be weak enough to allow the userto break off (see FIG. 13) the front lancet, e.g., to allow the user tobreak off the lancet L1 from the rear adjacent lancet L2. In thisregard, the invention contemplates that the connection can be formed byany convenient and/or practical arrangement such as, e.g., adhesivelybonding or ultrasonically welding, the members CM to the contactsurfaces CS. The connection can also be made breakable in any desiredway provided that a user can cause separation of the lancets in a simpleway by, e.g., twisting and/or bending. As can be seen in FIG. 13,breaking off the front lancet L1 exposes the lancet needle LN of therear adjacent lancet L2. As a result, the lancet needle LN of the rearadjacent lancet L2 remains protected within the opening LNO of the frontlancet L1 while the front lancet L1 is connected to the rear adjacentlancet L2.

Each lancet, e.g, lancet L1, also includes a front end from which thelancet needle LN extends or projects. A locking or retaining recess LRand a shoulder SP whose front surface forms a contact surface CS is alsoprovided on each lancet. By way of non-limiting example, the lockingrecess LR can be a tapered recess and can be specifically designed toengage with a locking or retaining member RM of a lancet holding memberLHM of a lancet device (see FIGS. 4-13). Of course, other mechanisms,other than a locking recess, can be utilized to ensure that the lancetunit LA is indexed or advanced in generally equal increments within thelancet holding member LHM. The invention contemplates that theparticular location, size and configuration of the retaining mechanismof each lancet can be specifically configured to a particular lancetholding member LHM of a particular lancet device.

The contact surface CS can be designed to contact an inner surface IS(which can be a movable/adjustable surface) of a lancet device tip (seee.g., FIG. 31). By way of non-limiting examples, the unit LA can be usedwith a lancet device (i.e., any of the lancet devices disclosed herein)which includes an adjustable tip or front cap FC (see FIG. 31) of thetype described in any one of the following documents: U.S. Pat. No.6,811,557 to SCHRAGA, U.S. Pat. No. 6,530,937 to SCHRAGA, U.S. Pat. No.6,322,575 to SCHRAGA, and U.S. Pat. No. 5,613,978 to HARDING, thedisclosures of which are hereby expressly incorporated by reference intheir entireties. By way of non-limiting examples, the unit LA can alsobe used with a lancet device (i.e., any of the lancet devices disclosedherein) which includes a non-adjustable tip or front cap FC (see FIG.31) of the type described in any one of the following documents: U.S.Pat. No. 6,156,051 to SCHRAGA, U.S. Pat. No. 6,022,366 to SCHRAGA, U.S.Pat. No. 5,908,434 to SCHRAGA, U.S. Pat. No. 5,797,942 to SCHRAGA, U.S.Pat. No. 5,628,764 to SCHRAGA, and U.S. Pat. No. 5,464,418 to SCHRAGA,the disclosures of which are hereby expressly incorporated by referencein their entireties. The above noted tips, as well as any of the tipsknown in the prior art, can also be used with any of the lancet devicesdescribed herein such as the ones shown in FIGS. 17, 18, 20-23, 26 and28-30. Additionally, the tip or front cap FC can be secured (e.g.,non-removably secured or removably secured) to the lancet devicesdisclosed herein by any conventionally known arrangements such asthreads, a snap connection, etc.

The body CBP of the lancets L1, L2, L3, LL and DL can be made of anyconventional material of which conventional lancets are made such as,e.g., synthetic resin. They can also be made by any conventional lancetmaking techniques including, e.g., injection molding, extrusion, etc.The lancet needles LN can also be of the same material, types and sizesas are used in conventional lancets. The number of lancets in aparticular unit LA can also vary depending on the desired numberrequired for a unit LA. It will also depend on the desired overall axiallength of the unit LA. Preferably, the overall unit LA has an axiallength of between approximately 1″ and approximately 5″ depending on thenumber of lancets in a unit LA and the length of each lancet. By way ofnon-limiting example, each lancet can also range in axial length betweenapproximately ¼″ and approximately ¾″. In order to provide a visualindicator to a user, the last lancet LL, and optionally also lancet DL,can be made of different color than the lancets L1-L3. In this way, whenthe user uses the unit LA in a lancet device (see e.g., FIGS. 17-19),upon seeing and using the last lancet LL, the user will be able to notethat it is time to change the unit LA with a new unit LA.

FIGS. 4-13 illustrate one non-limiting way in which the unit LA can bemounted to a lancet holding member LHM of a lancet device. Generallyspeaking, most lancet devices utilize a lancet holding member. Thelancet holding member is typically movably mounted within the lancetdevice and is usually moved and/or biased by one or more springs. Inmany lancet devices, the lancet holding member retains a replaceablelancet at a front location. Examples of such devices are disclosed inthe following documents: U.S. Pat. No. 6,811,557 to SCHRAGA, U.S. Pat.No. 6,530,937 to SCHRAGA, U.S. Pat. No. 6,346,114 to SCHRAGA, U.S. Pat.No. 6,190,398 to SCHRAGA, U.S. Pat. No. 6,156,051 to SCHRAGA, U.S. Pat.No. 6,022,366 to SCHRAGA, U.S. Pat. No. 5,908,434 to SCHRAGA, U.S. Pat.No. 5,797,942 to SCHRAGA, U.S. Pat. No. 5,628,764 to SCHRAGA, U.S. Pat.No. 5,464,418 to SCHRAGA, and U.S. Pat. No. 5,613,978 to HARDING, thedisclosures of which are hereby expressly incorporated by reference intheir entireties. According to one non-limiting example, the lancetholding member of one or more of the devices disclosed in thesedocuments is modified so as to use the unit LA disclosed herein. Thiscan occur by redesigning the lancet holding member of these devices soas to be hollow or tubular to allow for axial insertion of the unit LAin a manner similar to that shown in the lancet device of, e.g., FIG.20.

Again with reference to FIGS. 4-13, it can be seen that the lancetholding member LHM, which uses the unit LA, has a front end from which alancet L1 extends and through which the unit LA moves through. In orderto ensure that the unit LA advances and/or indexes out of the front endone lancet at a time, the lancet holding member LHM includes a retainingmechanism RM. In the embodiment shown in FIGS. 4-13, the retainingmechanism RM has the form of a C-shaped clip (see FIG. 6). The retainingmechanism RM mounted to front end of the lancet holding member LHM viaoppositely arranged slots SL, which are sized slightly larger in widththan the retaining member RM in order to loosely receive therein theretaining member RM. In order to ensure that the retaining member RMremains mounted to the lancet holding member LHM, the retaining memberRM includes four retaining projections RP which are designed to preventthe retaining member RM from sliding out of engagement with the slotsSL. The retaining member RM includes tapered and/or angled inner edgesAIE which utilize an angle which is generally complementary to that ofthe retaining recesses LR (see FIG. 10). As can be seen when comparingFIGS. 10-12, the retaining member RM is made of a resilient orspring-like material which can be deflected outwards (see FIG. 11) whenthe unit LA is moved out of the front end of the lancet holding memberLHM. The angles of the edge AIE and the recess LR are such that theyfacilitate outward deflection of legs of the retaining member RM whenthe unit LA is moved in the direction shown in FIG. 11. However, becausethe retaining member RM has the properties of a natural spring, when theunit LA is advanced out by the length of a lancet, the edges AIE againengage with another retaining recess LR thereby locking the unit LA inthe next position (see FIG. 12).

According to this embodiment, the used lancet L1 can the be separatedand/or broken off from the unit LA (see FIG. 13) using either a twistingmotion and/or a bending motion. At this point, the lancet needle LN ofthe next or new lancet L2 is ready for use. The user can then installthe tip of the lancet device and use it to pierce the skin. In thisembodiment, the user grips the used lancet L1 and pulls on the usedlancet L1 (FIG. 11) to cause the unit LA to advance forward. Theretaining member RM, by virtue of its angled inner edge AIE, preventsthe unit LA from moving back into the lancet holding member LHM even ifthe user desired it to so move, which functions as a safety feature. Ofcourse, pulling of the lancet L1 has the possibility of pricking theuser because the lancet needle LN is exposed. Accordingly, it ispreferred that the lancet device, which uses the lancet holding memberLHM shown in FIGS. 4-13, also use a system for advancing the unit LAthat does not require the user to handle the lancets during pulling,even though it may be necessary to do so to disconnect the lancet L1from the lancet L2. By way of non-limiting example, FIGS. 29 and 30 showone such a system which can be used with any of the lancet holdingmembers described herein. The details of FIGS. 29 and 30 will bedescribed later on.

FIGS. 14-16 illustrate another non-limiting way in which the unit LA canbe mounted to a lancet holding member LHM′ of a lancet device. Examplesof lancet devices which can use the lancet holding member LHM′ aredisclosed in the following documents: U.S. Pat. No. 6,811,557 toSCHRAGA, U.S. Pat. No. 6,530,937 to SCHRAGA, U.S. Pat. No. 6,346,114 toSCHRAGA, U.S. Pat. No. 6,190,398 to SCHRAGA, U.S. Pat. No. 6,156,051 toSCHRAGA, U.S. Pat. No. 6,022,366 to SCHRAGA, U.S. Pat. No. 5,908,434 toSCHRAGA, U.S. Pat. No. 5,797,942 to SCHRAGA, U.S. Pat. No. 5,628,764 toSCHRAGA, U.S. Pat. No. 5,464,418 to SCHRAGA, and U.S. Pat. No. 5,613,978to HARDING, the disclosures of which are hereby expressly incorporatedby reference in their entireties.

Again with reference to FIGS. 14-16, it can be seen that the lancetholding member LHM′ has a front end from which a lancet L1 extends andthrough which the unit LA moves through. In order to ensure that theunit LA advances and/or indexes out of the front end one lancet at atime, the lancet holding member LHM′ includes oppositely arrangedretaining members or mechanisms RM′. In the embodiment shown in FIGS.14-16, the retaining mechanisms RM′ are integrally formed with thelancet holding member LHM′ (see FIG. 15). The retaining mechanisms RM′are arranged on the front end of the lancet holding member LHM′ and arecapable of deflecting outwards when the unit LA is moved outwardly (seeFIG. 16). The retaining members RM′ include tapered and/or angled inneredges AIE′ which utilize an angle which is generally complementary tothat of the retaining recesses LR (see FIG. 14). As can be seen whencomparing FIGS. 14 and 16, the retaining members RM′ are made of aresilient or spring-like material which can be deflected outwards (seeFIG. 16) when the unit LA is moved out of the front end of the lancetholding member LHM′. The angles of the edge AIE′ and the recess LR aresuch that they facilitate outward deflection of the retaining membersRM′ when the unit LA is moved in the direction shown in FIG. 16.However, because the retaining members RM′ have the properties of anatural spring, when the unit LA is advanced out by the length of alancet, the edges AIE′ again engage with another retaining recess LRthereby locking the unit LA in the next position.

FIGS. 17-21 illustrate one non-limiting preferred embodiment of a unitLA and a lancet device LD which can utilize the unit LA. The lancetdevice LD utilizes a two part body made of an upper housing UH and alower housing LH which can be connected to each other by, e.g., snapconnection, adhesive bonding, or ultrasonic welding. The housing partsUH and LH can be made of the same conventional materials as are used inconventional lancet devices and are preferably made of synthetic resin.A trigger button TB is mounted to the body and functions to cause thelancet holding member LHM to move to an extended position when it isactivated. Examples of lancet devices which can use similar triggerbuttons are disclosed in the following documents: U.S. Pat. No.6,811,557 to SCHRAGA, U.S. Pat. No. 6,346,114 to SCHRAGA, U.S. Pat. No.6,156,051 to SCHRAGA, U.S. Pat. No. 5,908,434 to SCHRAGA, U.S. Pat. No.5,797,942 to SCHRAGA, U.S. Pat. No. 5,628,764 to SCHRAGA, U.S. Pat. No.5,464,418 to SCHRAGA, and U.S. Pat. No. 5,613,978 to HARDING, thedisclosures of which are hereby expressly incorporated by reference intheir entireties.

As can be seen when comparing FIGS. 18 and 20, the lancet holding memberLHM of the lancet device LD is hollow and/or tubular and is sized toreceive therein the unit LA. The lancet device LD has a rear opening ROwhich is aligned with the opening of the lancet holding member LHM. Thisopening RO allows the user to insert that unit shown in FIG. 19 into thelancet holding member LHM from the rear end of the lancet device LD.Once installed therein (see FIG. 20), the protective cap RC can beremoved. After the tip is installed (not shown) on the lancet device LD,the lancet device LD will then be ready for use in pricking a user'sskin. After use, the user simply removes the tip, pulls on the usedlancet L1 until the unit LA advances to the next lancet L2. The userwill then be able to break off the used lancet (see e.g., FIGS. 12 and13) thereby exposing the next new lancet L2. The lancet device LD willthen be ready for use once again after replacement of the tip on thelancet device LD. FIG. 21 shows how the lancet holding member LHM movesto the extended position under the action of the spring S once thetrigger button TB is activated. In order to ensure that the lancetholding member LHM is guided within the lancet device LD in a generallylinear manner without also rotating to a significant extent, the lancetdevice LD uses two or more spaced apart guiding flanges GF. In order toensure that the spring S also biases the lancet holding member LHM backinto the lancet device LD after it has moved to the extended position,the spring S has one end coupled to the body and another end coupled tothe lancet holding member LHM. Since the use of springs and triggerbuttons, as well as the interaction of the trigger button with thelancet holding member, on lancet devices is well know, the details ofsuch devices and arrangements will not be discussed in detail herein.

FIG. 22 illustrates one non-limiting optional configuration in order toensure that the lancet holding member LHM″ of the lancet device LD islinearly guided within the lancet device LD without rotating. Thearrangement uses an elongated guiding projection that is integrallyformed with the lancet holding member LHM″ and which acts to linearlyguide the movement of the lancet holding member LHM″ within the lancetdevice LD by engaging with grooves arranged on the guiding flanges GF′.The arrangement also uses guiding projections GP integrally formed withthe lancets (see FIGS. 24 and 25). The projections GP act to linearlyguide the movement of the unit LA′ within the lancet holding member LHM″when the unit LA′ is advanced between positions. As is evident from FIG.22, the projections GP slide within a groove formed in an insidecylindrical surface of the lancet holding member LHM″.

FIG. 23 illustrates another non-limiting optional configuration in orderto ensure that the lancet holding member LHM′″ of the lancet device LDis linearly guided within the lancet device LD without rotating. Thearrangement uses a polygonal-shaped, e.g., square or rectangular, lancetholding member LHM′″, which moves within a slightly larger butcorrespondingly shaped openings in the guiding flanges GF″. Thearrangement also uses guiding projections GP integrally formed with thelancets (see FIGS. 24 and 25). The projections GP act to linearly guidethe movement of the unit LA′ within the lancet holding member LHM′″ whenthe unit LA′ is advanced between positions. As is evident from FIG. 23,the projections GP slide within a groove formed in an inside cylindricalsurface of the lancet holding member LHM′″.

FIG. 26 illustrate another non-limiting preferred embodiment of a unitLA and a lancet device LD′ which can utilize the unit LA. The lancetdevice LD′ is similar to that shown in FIGS. 17, 19, 20 and 21 exceptthat it also includes a trigger setting mechanism TSM. The lancetholding member LHM^(IV) is similar to the one used in the embodimentshown in FIGS. 17, 19, 20 and 21 except that the rear end portionincludes a flange which can be gripped and/or engages by the triggersetting mechanism TSM. The use of such mechanisms on lancet devices arewell know and the invention is not limited to any particular type oftrigger setting mechanism. Examples of lancet devices which can usesimilar trigger setting arrangements are disclosed in the followingdocuments: U.S. Pat. No. 6,156,051 to SCHRAGA and U.S. Pat. No.6,022,366 to SCHRAGA, the disclosures of which are hereby expresslyincorporated by reference in their entireties.

FIG. 27 illustrate another non-limiting way in which the lancets can beconnected instead of and/or in addition to the connecting members CM. Inthis embodiment, the lancets of the unit LA″ are connected with one ormore wraps of connecting tape CT which includes a breakable perforationline PL in order to allow the user to separate the lancets from eachother. The connecting tape CT preferably is sufficiently thin so as notto cause the unit LA″ to become stuck within the lancet holding memberLHM.

FIG. 28 illustrates another non-limiting optional configuration in orderto ensure that the lancet holding member LHM^(IV) of the lancet deviceLD is linearly guided within the lancet device LU) without rotating. Thearrangement uses a polygonal-shaped, e.g., square or rectangular, lancetholding member LHM^(IV) which moves within a slightly larger butcorrespondingly shaped opening in the guiding flanges GF″. Thearrangement also uses a polygonal-shaped, e.g., square or rectangular,unit LA′″ which moves with a slightly larger but correspondingly shapedopenings in the lancet holding member LHM^(IV).

FIGS. 29 and 30 illustrate another non-limiting embodiment of a lancetdevice LD″ which uses another embodiment of a lancet holding memberLHM^(V). The device is similar to that shown in FIGS. 17, 18, 20 and 21except that it also includes a lancet advancing system LAS. The systemLAS includes s slot formed on the lancet device body, a slot formed inthe lancet holding member LHM^(V), and a push-button slide member UAMwhich is biased by a spring SP and which slides moves inwards to engageone of the retaining recess LR, slides forwardly to cause advancingmovement of the unit LHM^(V). The user can then move the member UAMmanually back to an initial position in order to engage the unit LA″again. This arrangement for manually moving the unit can be used on anyof the lancet device embodiments disclosed herein. Moreover, theinvention is not limited to the particular arrangement shown herein andcan utilize other arrangements for more safely advancing the unit withinthe lancet holding member.

FIGS. 32-41 show another embodiment of the multi-lancet unit LA^(IV).This embodiment utilizes two or more lancets L1 and L2 arranged one infront of the other. The front lancet L1 has a generally cylindrical bodywhich includes a front projecting portion PP_(L1) from which a lancetneedle LN extends and a rear recess portion RR_(L1). The rear lancet L2also has a generally cylindrical body which includes a front projectingportion PP_(L2) from which a lancet needle LN extends and a rear recessportion RR_(L2). As is shown in FIG. 32, the rear recess portion RR_(L2)of the rear lancet L2 has a shorter axial length than the rear recessportion RR_(L1) of the front lancet L1. As is shown in FIG. 40, thisarrangement allows the lancet needle LN of the front lancet L1 to beforced into a retracted position when the front projecting portionPP_(L1) of the front lancet L1 is positioned in the rear recess portionRR_(L2). The advantage of this feature is that the user will not be ableto inadvertently use the lancet unit LA^(IV) more than twice. In orderto protect the user from being accidentally injured, e.g. when the userinitially inserts the lancet unit LA^(IV) into a holding member of alancet device (see e.g., FIG. 52), a cap RC′ is removably connected thefrom front projecting portion PP_(L1) of the first lancet L1.

One non-limiting way of using the lancet unit LADS will now bedescribed. As is shown in FIGS. 33 and 34, once installed in a lancetdevice (not shown), the user can remove the cap RC′. The lancet can nowbe used to puncture the skin of a user. FIG. 35 shows the multi-lancetunit after the multi-lancet unit LA^(IV) is used to puncture the skin ofa user. The needle LN which has been used is shown to have contaminatesCT, e.g., blood. As is shown in FIGS. 36-39, the user can now separatethe used front lancet L1 from the unused rear lancet L2. Next, the userplaces the rear lancet L2 in front of the front lancet L1. The user canthen force the projecting portion PP_(L1) of the front lancet L1 intothe rear recess portion RR_(L2) of the rear lancet L2. This causes thelancet needle LN of the front lancet L1 to retract and essentiallyrenders this lancet unusable again. At this point, the multi-lancet unitLA^(IV) is ready to again be placed in the lancet device and usedpuncture the skin of a user with a fresh needle, i.e., the needle LN ofthe rear lancet L2 which has assumed the position of the front lancet.Once used again, the multi-lancet unit LA^(IV) can be fitted with thesafety cap RC′, and discarded. The lancet unit LA^(IV) now cannot beused again because, if the user tries to place the front lancet L1 backin front of the rear lancet L2, the needle LN of the front lancet L1will be retracted and the user will therefore have a visual indicatorthat the unit LA^(IV) has already been used twice (i.e., reached itsuseful life) and that it is time to use new lancet unit LA^(IV).

FIGS. 42-49 show another embodiment of the multi-lancet unit LA^(V).This embodiment also utilizes two or more lancets L1 and L2 arranged onein front of the other. The front lancet L1 has a generally cylindricalbody which includes a front projecting portion PP_(L1) from which alancet needle LN extends and a rear recess portion RR_(L1). The rearlancet L2 also has a generally cylindrical body which includes a frontprojecting portion PP_(L2) from which a lancet needle LN extends and arear recess portion RR_(L2). As is shown in FIG. 42, unlike the previousembodiment, the rear recess portion RR_(L2) of the rear lancet L2 hassubstantially the same axial length as the rear recess portion RR_(L1)of the front lancet L1. As is shown in FIG. 49, this arrangement allowsthe front projecting portion PP_(L1) of the front lancet L1 to be lockedwithin the rear recess portion RR_(L2) of the rear lancet L2. Theadvantage of this feature is that the user will not be able toinadvertently use the lancet unit LA^(V) more than twice. In order toprotect the user from being accidentally injured, e.g. when the userinitially inserts the lancet unit LA^(V) into a holding member of alancet device (see e.g., FIG. 52), a cap RC″ is removably connected thefrom front projecting portion PP_(L1) of the first lancet L1.

One non-limiting way of using the lancet unit LA^(V) will now bedescribed. As is shown in FIGS. 43 and 44, once installed in a lancetdevice (not shown), the user can remove the cap RC″. The lancet can nowbe used to puncture the skin of a user. FIGS. 45-46 shows themulti-lancet unit after the multi-lancet unit LA^(V) is used to puncturethe skin of a user. The user can then separate the used front lancet L1from the unused rear lancet L2. Next, as shown in FIGS. 47 and 48, theuser places the rear lancet L2 in front of the front lancet L1. The usercan then force the projecting portion PP_(L1) of the front lancet L1into the rear recess portion RR_(L2) of the rear lancet L2. This causesa locking projection LP of the front lancet L1 to lock with a lockingrecess LR of the rear lancet L2. At this point, the multi-lancet unitLA^(V) is ready to again be placed in the lancet device and usedpuncture the skin of a user with a fresh needle, i.e., the needle LN ofthe rear lancet L2 which has assumed the position of the front lancet.Once used again, the multi-lancet unit LA^(V) can be fitted with thesafety cap RC′, and discarded. The lancet unit LA^(V) now cannot be usedagain because the user is prevented by the locking arrangement fromplacing the front lancet L1 back in front of the rear lancet L2 and theuser will therefore have a visual indicator that the unit LA^(V) hasalready been used twice (i.e., reached its useful life) and that it istime to use new lancet unit LA^(V).

FIG. 50 shows one non-limiting way in which a cap RC^(III) of theabove-noted embodiments can be connected to the front projecting portionPP_(L1) of the front lancet L1 or the front projecting portion PP_(L2)of the rear lancet L2. The cap RC^(III) is shown threadably connected tothe front projecting portion PP_(L1) of the front lancet L1. FIG. 51shows one non-limiting way in which the front and rear lancets L1 and L1can be connected to each other. The front projecting portion PP_(L2) ofthe rear lancet L2 is shown threadably connected to the rear recessportion RR_(L1) of the front lancet L1.

FIGS. 53-54 show another embodiment of the multi-lancet unit LA^(VI).This embodiment also utilizes two or more lancets L1 and L2 arranged onein front of the other. The front lancet L1 has a generally cylindricalbody which includes a front projecting portion PP_(L1) from which alancet needle LN extends and a rear recess portion RR_(L1). The rearlancet L2 also has a generally cylindrical body which includes a frontprojecting portion PP_(L2) from which a lancet needle LN extends and arear recess portion RR_(L2). As is shown in FIG. 53, the rear recessportion RR_(L2) of the rear lancet L2 has a shorter axial length as therear recess portion RR_(L1) of the front lancet L1 As is shown in FIG.54, this arrangement allows the lancet needle LN of the front lancet L1to be forced into a retracted position when the front projecting portionPP_(L1) of the front lancet L1 is positioned in the rear recess portionRR_(L2). In order to protect the user from being accidentally injured,e.g. when the user initially inserts the lancet unit LA^(VI) into aholding member of a lancet device (see e.g., FIG. 52), a cap RC^(IV) isremovably connected the from front projecting portion PP_(L1) of thefirst lancet L1. However, once the user places the cap RC^(IV) on thelancet unit after it is used a second time, the cap RC^(IV) becomesnon-removably connected the from front projecting portion PP_(L2) of therear lancet L2. The advantage of this feature is that the user will notbe able to inadvertently use the lancet unit LA^(VI) more than twice.

One non-limiting way of using the lancet unit LA^(VI) will now bedescribed. Once installed in a lancet device (not shown), the user canremove the cap RC^(IV). The lancet can now be used to puncture the skinof a user. The user can then separate the used front lancet L1 from theunused rear lancet L2. Next, the user places the rear lancet L2 in frontof the front lancet L1. The user can then force the projecting portionPP_(L1) of the front lancet L1 into the rear recess portion RR_(L2) ofthe rear lancet L2. This causes the lancet needle LN to retract as inthe embodiment shown in FIG. 32. At this point, the multi-lancet unitLA^(VI) is ready to again be placed in the lancet device and usedpuncture the skin of a user with a fresh needle, i.e., the needle LN ofthe rear lancet L2 which has assumed the position of the front lancet.Once used again, the multi-lancet unit LA^(VI) can be fitted with thesafety cap RC^(IV), and discarded. The lancet unit LA^(VI) now cannot beused again because the user is prevented by the locking engagement of alocking ring and a locking recess from removing the cap RC^(IV) from therear lancet L2. The user will therefore have a visual indicator that theunit LA^(VI) has already been used twice (i.e., reached its useful life)and that it is time to use new lancet unit LA^(VI).

FIGS. 55-56 show another embodiment of the multi-lancet unit LA^(VII).This embodiment also utilizes two or more lancets L1 and L2 arranged onein front of the other. The front lancet L1 has a generally cylindricalbody which includes a front projecting portion PP_(L1) from which alancet needle LN extends and a rear recess portion RR_(L1). The rearlancet L2 also has a generally cylindrical body which includes a frontprojecting portion PP_(L2) from which a lancet needle LN extends and arear recess portion RR_(L2). The rear recess portion RR_(L2) of the rearlancet L2 has substantially the same axial length as the rear recessportion RR_(L1) of the front lancet L1. The rear recess portion RR_(L2)of the rear lancet L2 has a locking recess which, as is shown in FIG.56, locks with a lock ring arranged on the front projecting portionPP_(L1) of the front lancet L1. In order to protect the user from beingaccidentally injured, e.g, when the user initially inserts the lancetunit LA^(VII) into a holding member of a lancet device (see e.g., FIG.52), a cap RC^(V) is removably connected the from front projectingportion PP_(L1) of the first lancet L1. However, once the user placesthe cap RC^(V) on the lancet unit after it is used a second time, thecap RC^(IV) becomes non-removably connected the from front projectingportion PP_(L2) of the rear lancet L2. The cap RC^(V) has a lockingrecess which, as is shown in FIG. 56, locks with a lock ring arranged onthe front projecting portion PP_(L2) of the rear lancet L2. Theadvantage of this feature is that the user will be prevented from againusing the lancet unit LA^(VII) more than twice. Furthermore, the lancetunit LA^(VII) can now be safely discarded. Of course, the inventioncontemplates other locking mechanisms other than a lock ring and alocking recess.

One non-limiting way of using the lancet unit LA^(VII) will now bedescribed. Once installed in a lancet device (not shown), the user canremove the cap RC^(V). The lancet can now be used to puncture the skinof a user using the needle LN of the front lancet L1. The user can thenseparate the used front lancet L1 from the unused rear lancet L2. Next,the user places the rear lancet L2 in front of the front lancet L1. Thiscauses the two lancets L1 and L2 to become locked to each other via thelocking ring of the projecting portion PP_(L1) of the front lancet L1becoming locked with the locking recess of the rear recess portionRR_(L2) of the rear lancet L2. At this point, the multi-lancet unitLA^(VII) is ready to again be placed in the lancet device and usedpuncture the skin of a user with a fresh needle, i.e., the needle LN ofthe rear lancet L2 which has assumed the position of the front lancet.Once used again, the multi-lancet unit LA^(VII) can be fitted with thesafety cap RC^(V), and discarded. The lancet unit LAV^(II) now cannot beused again because the user is prevented by the locking engagement of alocking ring and a locking recess from removing the cap RC^(V) from therear lancet L2. The user will therefore have a visual indicator that theunit LA^(VII) has already been used twice (i.e., reached its usefullife) and that it is time to use new lancet unit LA^(VII).

The invention also contemplates a lancet unit which uses the lockingsystem of the embodiment shown in FIG. 32 with the cap locking systemused in the embodiment shown in FIGS. 53-54. Still further, theinvention contemplates using two lancets labeled A and B of 1 and 2 withthe front lancet L1 having the letter A or number 1 and the rear lancetL2 having the letter B or number 2. Once the lancet unit is used topuncture the skin of a user, the user can then separate the used frontlancet L1 from the unused rear lancet L2. Next, the user places the rearlancet L2 in front of the front lancet L1. The user now know that he hasalready used the unit twice because the lancet labeled 2 or B isarranged in front of the lance labeled 1 or A. This feature can also beused on any of the above-noted embodiments to provide additional visualindicators. The two lancets can also be made of different colors. Thecap will have the same color as the front lancet so that when the cap isplaced on the rear lancet, it will indicate that the unit has alreadybeen used twice. This feature also can be used on any of the above-notedembodiments to provide additional visual indicators.

The lancet devices can preferably made transparent and/or translucent sothat a user will clearly be able to see the inner workings of the deviceand note how much of the unit has already been utilized. Of course, theinvention is not limited to a body design which is transparent and/ortranslucent.

All the parts of the lancet device, with the exception of the springsand needles (which can respectively be made of spring steel andstainless steel), may be made from plastic materials and can be formedusing conventional injection molding techniques or other knownmanufacturing methods. However, when practical, other materials andmanufacturing processes may also be utilized. In each of the disclosedembodiments, the lancets which make up the multi-lancet unit can beformed individually (e.g., by injection molding) and then connectedtogether as described above. However, the invention also contemplatesforming the multi-lancet unit (e.g., by injection molding) as aone-piece member. In this latter case, the lancet needles can be placed(e.g., at predetermined locations) within the mold(s) which will formthe multi-lancet unit. Then, the mold(s) is filled with the meltedplastic material. Of course, provision is made in the mold(s) forproducing the breakable connections will allow the lancets to beseparated from the unit.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

What is claimed is:
 1. A multi-lancet unit in combination with a lancetdevice, the combination comprising: a plurality of lancets arranged onein front of the other; a holding member receiving therein themulti-lancet unit; the holding member being movable at least between atrigger-set position and a puncturing position; a mechanism structuredand arranged to move the multi-lancet unit within the holding member;and each lancet comprising a front end, a needle which extends from thefront end, and a rear end, wherein the front end of at least one of theplurality lancets is removably connected to the rear end of another ofthe plurality of lancets.
 2. The combination of claim 1, wherein theplurality of lancets comprises two lancets.
 3. The combination of claim1, wherein the plurality of lancets comprises at least three lancets. 4.The combination of claim 1, wherein the plurality of lancets is betweenfive lancets and twenty lancets.
 5. The combination of claim 1, whereinthe plurality of lancets is between eight lancets and twelve lancets. 6.The combination of claim 1, wherein each of the plurality of lancetscomprises a generally cylindrical portion.
 7. The combination of claim1, wherein each of the plurality of lancets comprises a non-circularcross-section when viewed perpendicular to a center axis of theplurality of lancets.
 8. The combination of claim 1, wherein at leastone of the plurality of lancets comprises a locking mechanism.
 9. Thecombination of claim 8, wherein the locking mechanism is one of alocking recess and a locking projection.
 10. The combination of claim 1,wherein at least one of the plurality of lancets comprises at least oneof a locking recess and a locking member.
 11. The combination of claim1, wherein the needle of at least one of the plurality of lancets isretractable.
 12. The combination of claim 1, further comprising: a depthadjustment mechanism; a cocking mechanism; and a locking or retainingmechanism arranged on the holding member.
 13. A method of puncturing asurface of skin using the lancet device of claim 1, the methodcomprising: arranging the lancet device adjacent against a user's skin;and triggering the lancet device so that one of the plurality of lancetsis caused to penetrate the user's skin.
 14. A method of puncturing asurface of skin using the lancet device of claim 1, the methodcomprising: arranging the lancet device adjacent against a user's skin;triggering the lancet device so that one of the plurality of lancets iscaused to penetrate the user's skin; and after triggering, removing aforward-most lancet.
 15. A method of puncturing a surface of skin usingthe lancet device of claim 1, the method comprising: arranging thelancet device adjacent against a user's skin; triggering the lancetdevice so that one of the plurality of lancets is caused to penetratethe user's skin; and after triggering, moving the multi-lancet forwardlyusing the mechanism.
 16. A method of making the multi-lancet unit ofclaim 1, the method comprising: forming each of the plurality oflancets; arranging the plurality of lancets in a row to form themulti-lancet unit; and inserting the multi-lancet unit into the holdingmember of the lancet device.
 17. A multi-lancet unit in combination witha lancet device, the combination comprising: a plurality of lancetsarranged in a row; a holding member receiving therein the multi-lancetunit; the holding member being movable at least between a trigger-setposition and a puncturing position; a mechanism structured and arrangedto move the multi-lancet unit within the holding member between aplurality of predetermined axial positions; and each lancet comprising afront end, a needle which extends from the front end, a rear end, anopening extending into the rear end, wherein the front end of at leastone of the plurality lancets is removably connected to the rear end ofanother of the plurality of lancets.
 18. The combination of claim 17,wherein the plurality of lancets comprises two lancets.
 19. Thecombination of claim 17, wherein the plurality of lancets comprises atleast three lancets.
 20. The combination of claim 17, wherein theplurality of lancets is between five lancets and twenty lancets.
 21. Thecombination of claim 17, wherein the plurality of lancets is betweeneight lancets and twelve lancets.
 22. The combination of claim 17,wherein each of the plurality of lancets comprises a generallycylindrical portion.
 23. The combination of claim 17, wherein each ofthe plurality of lancets comprises a non-circular cross-section whenviewed perpendicular to a center axis of the plurality of lancets. 24.The combination of claim 17, wherein one of the plurality of lancets isconfigured to be non-removably connected to another of the plurality oflancets.
 25. The combination of claim 17, wherein one of the pluralityof lancets is configured to be non-removably connected to another of theplurality of lancets after said lancets are separated from each otherand connected to each other in a different configuration.
 26. Thecombination of claim 17, further comprising a cap which is configured tobe removably connected to one of the plurality of lancets and configuredto be non-removably connected to another of the plurality of lancets.27. The combination of claim 17, further comprising: a depth adjustmentmechanism; a cocking mechanism; and a locking or retaining mechanismarranged on the holding member.
 28. A method of puncturing a surface ofskin using the lancet device of claim 17, the method comprising:arranging the lancet device adjacent against a user's skin; andtriggering the lancet device so that one of the plurality of lancets iscaused to penetrate the user's skin.
 29. A method of puncturing asurface of skin using the lancet device of claim 17, the methodcomprising: arranging the lancet device adjacent against a user's skin;and triggering the lancet device so that one of the plurality of lancetsis caused to penetrate the user's skin.
 30. A method of puncturing asurface of skin using the lancet device of claim 17, the methodcomprising: arranging the lancet device adjacent against a user's skin;triggering the lancet device so that one of the plurality of lancets iscaused to penetrate the user's skin; and after triggering, moving themulti-lancet forwardly using the mechanism.
 31. A method of making themulti-lancet unit of claim 17, the method comprising: forming each ofthe plurality of lancets; arranging the plurality of lancets in a row toform the multi-lancet unit; and inserting the multi-lancet unit into theholding member of the lancet device.
 32. A multi-lancet unit incombination with a lancet device, the combination comprising: aplurality of lancets arranged in a row; a holding member receivingtherein the multi-lancet unit; the holding member being movable at leastbetween a trigger-set position and a puncturing position; a mechanismstructured and arranged to move the multi-lancet unit within the holdingmember between a plurality of predetermined axial positions; themechanism comprising a portion arranged outside a body of the lancetdevice and said portion configured to be movable by a user; each lancetcomprising a front end, a needle which extends from the front end, arear end, an opening extending axially into the rear end; and a capremovably connected to a front one of the plurality of lancets.
 33. Thecombination of claim 32, further comprising: a depth adjustmentmechanism; a cocking mechanism; and a locking or retaining mechanismarranged on the holding member.